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The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty

Primary Purpose

Emergence Agitation, Anesthetics, Rhinoplasty

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
: Conventional flow Anesthesia
Low Flow Anesthesia
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Emergence Agitation focused on measuring Emergence Agitation, Anesthetics

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18-50 years ASA class I-II, scheduled for elective rhinoplasty surgery under general anesthesia Exclusion Criteria: history of allergy to nonsteroidal anti-inflammatory drugs, bleeding diathesis or anticoagulant use, psychiatric drug use, previous rhinoplasty surgery patient refusal

Sites / Locations

  • Ulku Ozgul

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Conventional group

Low Flow Group

Arm Description

Anesthesia induction will be performed with 2 mg/kg propofol, 1 µg/kg fentanyl and 0.6 mg/kg rocuronium as standard.After intubation, anesthesia will maintained with %40 O2 and sevoflurane at 2% volume. When the sevoflurane concentration reached 1 MAC, the fresh gas flow rate will be brought to 2 L/min. Inhalation anesthetics will be turned off 10 minutes before the end of the operation. The fresh gas flow will be increased to 6 l/min to be 100% O2. At the end of the surgery, the neuromuscular block will be antagonized with neostigmine-atropine. Sedation and agitation will be assessed immediately after extubation.

anesthesia induction will be performed with 2 mg/kg propofol, 1 µg/kg fentanyl and 0.6 mg/kg rocuronium as standard.After intubation, anesthesia will maintained with %40 O2 and sevoflurane at 2% volume. When the sevoflurane concentration reached 1 MAC, the fresh gas flow rate will be brought to 0.5 L/min. Inhalation anesthetics will be turned off 10 minutes before the end of the operation. The fresh gas flow will be increased to 6 l/min to be 100% O2. At the end of the surgery, the neuromuscular block will be antagonized with neostigmine-atropine. Sedation and agitation will be assessed immediately after extubation.

Outcomes

Primary Outcome Measures

Richmond Agitation-Sedation Scale (RASS)
Sedation and agitation will be assessed immediately after extubation with the Richmond Agitation-Sedation Scale. RASS is divided into 10 levels (score range, -5 to 4, higher scores indicate more agitation)

Secondary Outcome Measures

Ramsey Sedation Scale (RSS)
RSS is divided into 6 levels (score range, 1-6, lower scores indicate more agitation).
Boezaart score
the quality of the operating field in terms of bleeding (Boezaart score),Participating surgeons will rate surgical site visibility from 0 to 5 on the Boezaart rating scale, where 0 is the best and 5 is the worst.
Surgeon satisfaction
. Surgeon satisfaction with the operative field will be rated at the end of surgery using a 5-choice Likert scale: 1 = very bad, 2 = bad, 3 = fair, 4 = good, and 5 = excellent.

Full Information

First Posted
October 27, 2022
Last Updated
March 23, 2023
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05601674
Brief Title
The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty
Official Title
The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Emergence agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia; this may cause respiratory depression, nausea and vomiting, as well as an increase in blood pressure, heart rate and myocardial oxygen consumption. Although its pathogenesis remains unclear, ENT (ear, nose and throat) surgical procedures have been reported to have a higher incidence of agitation in both adults and children. In recent years, low-flow inhalation anesthesia has been widely used in adult anesthesia practice. The aim of this study is to compare the effects of low flow anesthesia and normal flow anesthesia on emergence agitation.
Detailed Description
Emergence agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia; this may cause respiratory depression, nausea and vomiting, as well as an increase in blood pressure, heart rate and myocardial oxygen consumption. Hypoxia can lead to serious complications such as aspiration pneumonia, bleeding or reoperation. Although its pathogenesis remains unclear, ENT (ear, nose and throat) surgical procedures have been reported to have a higher incidence of agitation in both adults and children. In recent years, low-flow inhalation anesthesia has been widely used in adult anesthesia practice. Low flow anesthesia has many advantages; the consumption of inhalation agents is reduced, the temperature and humidity of the airways are maintained, the cost of anesthesia and pollution caused by atmospheric waste gases are reduced. In addition, because the temperature and humidity of the tracheobronchial tree are preserved, respiratory functions and mucociliary activities are better preserved. In low-flow anesthesia, the concentration of inhaled anesthetics changes very slowly, and their concentration gradually decreases after the administration is terminated. Since the anesthetic concentration will slowly decrease in the low-flow group during termination of anesthesia, the concentration difference between the brain and lungs will be small. In addition, it is known that a longer period between discontinuation of the administration of anesthetic agents and extubation reduces emergence agitation. This seems possible with the low-flow anesthesia technique. The aim of this study is to compare the effects of low flow anesthesia and normal flow anesthesia on emergence agitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation, Anesthetics, Rhinoplasty
Keywords
Emergence Agitation, Anesthetics

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional group
Arm Type
Placebo Comparator
Arm Description
Anesthesia induction will be performed with 2 mg/kg propofol, 1 µg/kg fentanyl and 0.6 mg/kg rocuronium as standard.After intubation, anesthesia will maintained with %40 O2 and sevoflurane at 2% volume. When the sevoflurane concentration reached 1 MAC, the fresh gas flow rate will be brought to 2 L/min. Inhalation anesthetics will be turned off 10 minutes before the end of the operation. The fresh gas flow will be increased to 6 l/min to be 100% O2. At the end of the surgery, the neuromuscular block will be antagonized with neostigmine-atropine. Sedation and agitation will be assessed immediately after extubation.
Arm Title
Low Flow Group
Arm Type
Active Comparator
Arm Description
anesthesia induction will be performed with 2 mg/kg propofol, 1 µg/kg fentanyl and 0.6 mg/kg rocuronium as standard.After intubation, anesthesia will maintained with %40 O2 and sevoflurane at 2% volume. When the sevoflurane concentration reached 1 MAC, the fresh gas flow rate will be brought to 0.5 L/min. Inhalation anesthetics will be turned off 10 minutes before the end of the operation. The fresh gas flow will be increased to 6 l/min to be 100% O2. At the end of the surgery, the neuromuscular block will be antagonized with neostigmine-atropine. Sedation and agitation will be assessed immediately after extubation.
Intervention Type
Other
Intervention Name(s)
: Conventional flow Anesthesia
Intervention Description
During the initial wash-in period 2 L/min Fresh gas flow will be used.
Intervention Type
Other
Intervention Name(s)
Low Flow Anesthesia
Intervention Description
Fresh gas flow rate will be 0.5 L/min throughout the procedure.
Primary Outcome Measure Information:
Title
Richmond Agitation-Sedation Scale (RASS)
Description
Sedation and agitation will be assessed immediately after extubation with the Richmond Agitation-Sedation Scale. RASS is divided into 10 levels (score range, -5 to 4, higher scores indicate more agitation)
Time Frame
From extubation to 30 minutes of arrival in the postoperative care unit
Secondary Outcome Measure Information:
Title
Ramsey Sedation Scale (RSS)
Description
RSS is divided into 6 levels (score range, 1-6, lower scores indicate more agitation).
Time Frame
From extubation to 30 minutes of arrival in the postoperative care unit
Title
Boezaart score
Description
the quality of the operating field in terms of bleeding (Boezaart score),Participating surgeons will rate surgical site visibility from 0 to 5 on the Boezaart rating scale, where 0 is the best and 5 is the worst.
Time Frame
immediate postoperative period
Title
Surgeon satisfaction
Description
. Surgeon satisfaction with the operative field will be rated at the end of surgery using a 5-choice Likert scale: 1 = very bad, 2 = bad, 3 = fair, 4 = good, and 5 = excellent.
Time Frame
immediate postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-50 years ASA class I-II, scheduled for elective rhinoplasty surgery under general anesthesia Exclusion Criteria: history of allergy to nonsteroidal anti-inflammatory drugs, bleeding diathesis or anticoagulant use, psychiatric drug use, previous rhinoplasty surgery patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulku Ozgul, Professor
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulku Ozgul
City
Malatya
ZIP/Postal Code
44090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20526708
Citation
Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.
Results Reference
result

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The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty

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